NDAORALCAPSULE
Approved
May 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
PROMETRIUM (progesterone) by Fresenius Kabi is clinical pharmacology prometrium capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. First approved in 1998.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROMETRIUM is an oral micronized progesterone capsule that is chemically identical to naturally occurring progesterone. It is used primarily in hormone replacement therapy and progesterone supplementation for postmenopausal women and other indications requiring progesterone support. The micronization formulation enhances oral bioavailability, achieving peak serum concentrations within 1.5–2.3 hours of administration.
LOE Approaching
Product is approaching loss of exclusivity with limited team expansion expected; career focus likely shifts to managed decline or transition to next-generation formulations.
Mechanism of Action
CLINICAL PHARMACOLOGY PROMETRIUM Capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. The oral bioavailability of progesterone is increased through micronization. Pharmacokinetics A. Absorption After oral administration of…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.